Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- visal analogue scale (VAS) score
研究概览
简要总结
This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and transcutaneous nerve stimulation (TENS) for pain relieving in patients with pancreatic cancer. Patients will randomly allocated into PENS group, Tens group and control group.
详细描述
PENS and TENS have been reported with analgesic effect in patients with pain, including cancer pain, lower back pain, neck pain, stomachache and so on.
Effect and mechanism of PENS on pain relieving has been widely researched. With additional electrical stimulation in certain frequency and intensity to conventional acupuncture, pain controlling effect has been largely enhanced. However, invasive operation limits its application and acceptability, especially on pancreatic cancer.
TENS is an advanced technique generated from PENS, which is much more welcome for its noninvasive character. Further more, its analgesic effect on cancer pain has been proved by several multi-central, randomized, clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant is allocated randomly by staff A, and grouping situation is concealed; Technician (stuff B) or chargeing docotor operates PENS or TENS, or administers oral analgesic medication; Related datas are collected according to perdetermined forms by stuff C; Outcomes are assessed by stuff D.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreatic cancer with pain;
- •Haven't underwent neurolytic celiac plexus block in the past 1 month;
- •With anticipatory survival of more than 3 months.
排除标准
- •Metastatic pancreatic cancer;
- •Can not tolerate 30 min of lieing in prostrate or side position;
- •Who has been recruited in other clinical trial for pain releiving;
- •Who underwent radiotherapy or local radiactive seeds implantation for pain releiving in the past month;
- •Imaging diagnosed with encephalic tumor or metastasis;
- •Who with cardiac pacemaker or metal stand;
研究组 & 干预措施
percutaneous stimulation
PENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
干预措施: PENS (Device)
trancutaneous stimulation
TENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
干预措施: TENS (Device)
Control
Conventional analgesic medication is offered.
结局指标
主要结局
visal analogue scale (VAS) score
时间窗: D0-D6
VAS score before,during and 3 days after treatment
次要结局
- quantity of analgesic medication(D0-D6)
- times of breakthrough pain (BTP)(D0-D6)